LEVETIRACETAM
- Product NDC
- 55488-0519
- 11-digit product format
- 554880519
- Labeler code
- 55488
- Product ID
- 55488-0519_7ccdb5b2-160c-44eb-bbc3-b869e5323754
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Changzhou Pharmaceutical Factory
- Application
- ANDA212688
- Marketing category
- ANDA
- Marketing start
- 2020-06-11
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 750 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55488-0519-1 | LEVETIRACETAMExtended-release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55488-0519 | LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [CHANGZHOU PHARMACEUTICAL FACTORY] | 3 | Legacy NDC, 1 package rows | 20200625_5d3ce612-94de-4ad3-b873-27cb09304d45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55488-0519-1 | 55488051901 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55488-0519-1) | 2020-06-11 | 0000-00-00 | No | No | Current |